The Therapeutic Effect of Computer-assisted Cognitive Function Training on Cognitive Dysphagia After Stroke

March 2, 2024 updated by: Zeng Changhao

The Therapeutic Effect of Computer-assisted Cognitive Function Training on Cognitive Dysphagia After Stroke: A Randomized Controlled Study

This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Computer-assisted cognitive training is a rehabilitation method that uses computer technology and psychological principles to promote the recovery of cognitive function.This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Zheng da yi fu yuan hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Meeting the diagnostic criteria for traumatic brain injury, confirmed by magnetic resonance imaging or CT scan.
  • Montreal Cognitive Assessment score < 26 and > 18 (adjusted by 1 point if the educational level is high school graduation or above).
  • Confirmed swallowing disorder through Fiberoptic Endoscopic Examination of Swallowing.
  • Duration of illness greater than three months.
  • Patients or their family members are aware of and consent to participate in the study.

Exclusion Criteria:

  • Presence of other intracranial lesions, such as stroke.
  • Cognitive impairment caused by other diseases.
  • Mental abnormalities.
  • Inability to complete treatment and assessments due to other impairments.
  • Concurrent severe injuries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the experimental group
In this study, each patient received a continuous 15-day treatment. During the treatment, both groups of patients received routine rehabilitation treatment. The experimental group additionally underwent computer-assisted cognitive training, which generated training content of corresponding difficulty based on the patient's cognitive impairment assessment results. The training was conducted seven days a week, once a day, for a duration of 30-45 minutes per session.
Behavioral: routine rehabilitation treatment
The routine rehabilitation treatment included intervention for risk factors (such as blood pressure, blood lipids, and blood glucose control, restriction of smoking and alcohol, exercise, etc.) Besides, the patients with stable vital signs were scheduled for specialized rehabilitation training upon enrollment, and targeted rehabilitation programs were selected, conducted by experienced rehabilitation therapists.
Behavioral: Computer-assisted Cognitive Function Training
Based on the patient's cognitive impairment assessment results, the training content includes Attention game training, Executive function program training, Logical reasoning training, Agility training, Memory training. The training is conducted seven days a week, once a day, for a duration of 30-45 minutes per session
Active Comparator: the control group
In this study, each patient received a continuous 15-day treatment. During the treatment, both groups of patients received routine rehabilitation treatment.The control group was given conventional cognitive training.
Behavioral: routine rehabilitation treatment
The routine rehabilitation treatment included intervention for risk factors (such as blood pressure, blood lipids, and blood glucose control, restriction of smoking and alcohol, exercise, etc.) Besides, the patients with stable vital signs were scheduled for specialized rehabilitation training upon enrollment, and targeted rehabilitation programs were selected, conducted by experienced rehabilitation therapists.
Behavioral: conventional cognitive training
including Memory training, attention training, and executive function training were conducted 2-5 times per week, lasting for 30-60 minutes each session, based on the patient's condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: day 1 and day 15
The Montreal Cognitive Assessment is used for assessing cognitive function.The total score on the test is 30, the higher scores indicating the higher cognitive function
day 1 and day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The coordination of swallowing
Time Frame: day 1 and day 15
Observation of the coordination of laryngeal and vocal fold movements. Results are categorized as normal/abnormal.
day 1 and day 15
Penetration-Aspiration Scale
Time Frame: day 1 and day 15
Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased.
day 1 and day 15
Swallowing duration
Time Frame: day 1 and day 15
The time duration that the patient swallowed the contrast agent under Videofluoroscopic Swallowing Study the was recorded.Unit: seconds.
day 1 and day 15
Swallowing reflex
Time Frame: day 1 and day 15
Observation of the ability to initiate swallowing movements during eating, manifested by the white-out phenomenon seen under flexible laryngoscopy. Results are categorized as normal or abnormal.
day 1 and day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeng Changhao

Collaborators

The First Affiliated Hospital of Zhengzhou University

Investigators

  • Principal Investigator: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-KY-1229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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